The European Medicine Agency’s main scientific committee has issued positive opinions for three new medicines, including a new oral contraceptive. In addition, it has given a positive assessment to a C1 inhibitor that is similar to a marketed product.
The European Medicines Agency and the US Food and Drug Administration have announced plans to increase the efficiency of the drug regulatory process by evaluating, in parallel, the quality components of certain new drug applications.
The US Food and Drug Administration announced that it has taken action against the Johnson & Johnson subsidiary, McNeil-PPC, for failing to comply with current good manufacturing practice requirements at three sites.
The US Food and Drug Administration has announced the approval of Benlysta (belimumab) to treat patients with systemic lupus erythematosus. It is the first new drug to be approved for this disease since 1955. The developers are GSK and Human Genome Sciences.
An advisory panel of the US Food and Drug Administration has recommended approval of Novartis’s indacaterol as the first once-daily, long-term maintenance bronchodilator treatment for patients with chronic obstructive pulmonary disease.
The European Court of Justice (ECJ) has struck down a proposal from member states of the European Union to create a new, unified jurisdiction for the litigation of patent disputes saying the proposal is incompatible with the EU treaties.
AstraZeneca Plc and Bristol-Myers Squibb Co have won a label update in Europe and the US for their Type 2 diabetes drug, Onglyza (saxagliptin), for adults with Type 2 diabetes who have moderate or severe renal impairment.
An investigational drug for patients with Type 2 diabetes has failed to show non-inferiority in a clinical trial that compared it with a competitor. The drug, Bydureon, is an extended release formulation of exenatide.
Merck Serono has received a ‘complete response letter’ from the US Food and Drug Administration rejecting its proposed multiple sclerosis treatment, cladribine. The company withdrew its European application for the same drug in February.
The Committee for Medicinal Products for Human Use has issued positive opinions for three new medicines and restrictions on the use of two. In addition, a new contraindication is being recommended for Merck’s Brinavess (vernakalant).